OneMain Financial Jobs

General Description:

BeOne Medicines is seeking a highly experienced R&D attorney with deep experience to provide comprehensive legal support for the global R&D function. As a key member of both the Legal and R&D leadership teams, you will play a pivotal role in navigating the complex legal landscape associated with research and development in the biotech sector.

This role will be a critical addition to the company, providing legal guidance, regulatory support, and risk management expertise to propel our oncology and inflammation & immunology research and development programs forward. The ideal candidate will possess a deep understanding of biotech and pharmaceutical law, intellectual property, and regulatory compliance, particularly as it pertains to R&D. As the Leader of the R&D Legal function this role will support all facets of R&D including Regulatory, Research, Development, Clinical Operations, Safety and Pharmacology.

Position is a remote role based in the US.

Essential Functions of the Job:

• Provide comprehensive legal support to the global R&D function, ensuring effective risk management and compliance with applicable laws and regulations.

• Partner with R&D leaders to shape and implement strategies that align with the company’s objectives and mission.

• Advise on regulatory matters affecting R&D, including clinical trials, product and companion diagnostics development, and submissions to regulatory authorities (e.g., FDA, EMA, CDE).

• Stay current on developments in laws and regulations affecting the biotech industry and advise internal stakeholders accordingly.

• Negotiate and draft a wide variety of agreements related to R&D, including collaboration agreements, licensing agreements, and clinical trial agreements.

• Ensure that contracts are compliant with legal standards and aligned with the company’s strategic goals.

• Collaborate closely with other departments to provide integrated legal support and guidance.

• Serve as a key advisor and stakeholder to promote a culture of compliance and ethical conduct in R&D programs.

• Build, lead, and mentor a high-performing legal team, fostering a collaborative and results-oriented environment.

• Identify and evaluate potential legal risks associated with R&D activities and develop strategies to mitigate these risks.

• Prepare and present legal analyses and recommendations to the executive team and Board of Directors.

Qualifications:

• 15+ years of relevant legal experience, which includes a focus on pharmaceutical, biotech, or related life science matters/clients, 5+ years of which should be in-house with a biotech/pharma company.

• A U.S. law degree (J.D.) and current “good standing” admission to at least one U.S. state bar.

• An ability to support global working hours.

• Must have demonstrable mastery of human subject research protection laws; Federal Food, Drug and Cosmetic Act and related regulations; US and global privacy laws; US fraud & abuse laws; and other applicable federal and state laws governing the research and development of human therapeutics.

• Must have significant experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, companion diagnostic developments, complex research collaborations and consortia.

Mandarin is a plus.

• Proven knowledge of biotech law, regulatory requirements, and intellectual property issues in the context of drug development.

• Strong negotiation and communication skills, with the ability to influence cross-functional stakeholders and drive legal initiatives.

• Experience managing a legal team and providing strategic direction.

• Exceptional analytical and problem-solving abilities, with a proactive approach to risk management.

• Ability to approach complex problems with a creative and growth mindset, able to navigate risks by providing mitigation strategies and pragmatic solutions.

• Experience with AI and digital health is helpful though not required, but a willingness to learn is a must.

• Excellent verbal and written communication skills, awareness and ability to engage with others in a global ecosystem, along with a confidence for advising VP-level leadership and swiftly responding to and de-escalating as needed

• Excellent judgment and superior business partnering skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary global colleagues and external partners.

• Ability to deliver clear, concise and practical advice and mitigation strategies regarding challenging legal issues to legal and non-legal colleagues, including senior management.

• Ability to prioritize and work with agility across multiple projects.

• Aptitude and interest to learn the scientific/technical side of the business.

Supervisory Responsibilities:

• Manage a global team

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.